Liver transplantation immunossupression, hepatic graft rejection and loss, receptor death, immunosuppressive drug myelotoxicity, posttransplant diabetes mellitus, posttransplant dyslipidemia, cytomegalovirus events, hepatic artery thrombosis, bile duct complications, operative wound complications, incisional hernia, postoperative kidney failure, proteinuria, discontinuation of the immunosuppressive regimen. Liver transplantation
Conditions
Interventions
Comparison group: 50 patients will receive everolimo (1mg 2x per day) orally, started when the platelet value is above 35,000 / mm3, and adjusted to target concentrations of 3-8 ng / mL for 12 months,
Drug
C16.131.042
E02.095.465.425.450.440
Sponsors
Hospital Geral de Fortaleza
Hospital Geral de Fortaleza
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Orthotopic whole organ liver transplant recipients; deceased donor; age above 18 years; both sexes; with graft functionality within 72h of reperfusion.
Exclusion criteria
Exclusion criteria: Patients with pre-transplant protein and urinary creatinine ratio greater than 1mg / g or proteinuria 24h greater than 1g; multiple organ transplant recipients; patients with hypercholesterolemia (greater than 350 mg / dL) or hypertriglyceridemia (greater than 500 mg / dL) severe if use of lipid-lowering therapy with controlled hyperlipidemia will be accepted; previously transplanted liver patients who progressed with graft loss and in need of retransplantation; patients with positive serology for HIV; women who are pregnant, who are planning to become pregnant, are pregnant or breastfeeding, or do not agree to use effective methods of contraception; patients with difficult decision making who are not judged medically or mentally capable of providing informed consent on their own.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: to evaluate the incidence of acute cellular rejection proven by needle biopsy, with histological analysis by Banff classification, when the rejection activity index is greater than or equal to 3.;Expected outcome 2: to evaluate cytomegalovirus events through donor and recipient IgM and IgG serologies, quantification of receptor polymerase chain reaction viremia, or diagnosis of cytomegalovirus infection or infection of the recipient (fever greater than or equal to 38 graus celsius, adynamia or fatigue, leukopenia or neutropenia, atypical lymphocytosis, thrombocytopenia, increased alanine aminotransferase or aspartate aminotransferase). The strategy is the preemptive treatment with cutoff quantification of viremia depending on the donor / recipient combination (positive or negative donor with negative receptor value greater than or equal to 2500 IU / mL, and positive or negative donor with positive receptor value greater than or equal to to 5000 IU / mL).;Expected outcome 3: to evaluate hepatic graft loss in 12 months of transplantation, defined by the need for liver transplantation.;Expected outcome 4: to assess patient survival after 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: to evaluate surgical complications of wound dehiscence, hepatic artery thrombosis, incisional hernia or biliary tract complications, diagnosed by physical examination and imaging tests (abdominal ultrasound with Doppler, computed tomography of the abdomen, cholangioressonance, endoscopic retrograde cholangiopancreatography). ;Expected outcome 3: Metabolic disorders, through the evaluation of glycemia, total cholesterol and triglycerides at months 3, 6, 9 and 12 after transplantation.;Expected outcome 4: to evaluate hematological parameters, by performing a complete blood count at months 3, 6, 9 and 12 after transplantation. ;Expected outcome 2: to evaluate renal function by calculating the MDRD equation and 24h proteinuria at months 3, 6, 9 and 12 after transplantation. | — |
Countries
Brazil
Contacts
Public ContactTiciana Esmeraldo
Hospital Geral de Fortaleza
Outcome results
None listed